Regulatory Affairs Manager

Accountabilities

• Conduct comprehensive regulatory and compliance reviews of ingredients, formulations, packaging, and marketing assets in line with applicable U.S. regulations (including FDA and dietary supplement frameworks)
• Review and validate product labels, structure/function claims, and marketing content to ensure compliance with FTC and FDA substantiation requirements
• Maintain and manage regulatory documentation including ingredient status, allergen declarations, GRAS/NDIN records, and other compliance files
• Act as a key regulatory liaison for cross-functional teams, providing timely guidance and clear compliance pathways for Brand, Creative, and Marketing requests
• Support GMP compliance activities including review of QMS documentation, change controls, specifications, and audit readiness materials
• Contribute to the development and optimization of SOPs, workflows, and automation initiatives to improve regulatory efficiency and scalability

Requirements

• Minimum 6 years of Regulatory Affairs experience in a GMP environment, with at least 4 years focused on dietary supplement regulatory reviews in the U.S.
• Bachelor’s degree in pharmaceutical, nutritional, life sciences, or related scientific field
• Strong knowledge of FDA dietary supplement regulations (including 21 CFR 111) and FSMA requirements
• Solid understanding of FTC advertising standards and structure/function claim compliance
• Experience with GMP documentation, labeling requirements, and regulatory substantiation practices
• Proven ability to collaborate in cross-functional teams and communicate regulatory guidance effectively
• Strong attention to detail, analytical thinking, and ability to manage multiple priorities in a fast-paced environment
• Preferred: experience with probiotic or live microbial products, and familiarity with international regulatory frameworks (EU, Canada, Australia)

Benefits

• Competitive salary range of $130,000–$150,000 annually, plus equity and comprehensive benefits
• 100% remote work within the United States
• Medical, dental, and vision insurance with multiple plan options and employer contributions
• Mental health support including therapy sessions, coaching, and digital wellness tools
• 401(k) plan with employer match and immediate vesting
• Generous parental leave and phased return-to-work options
• Flexible paid time off, including vacation, sick days, personal days, recharge days, and company holidays
• Home office and wellness stipends to support remote work and well-being
• Learning, development, and additional lifestyle benefits including pet insurance and disability coverage.

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